Vaccines and Related Biological Products Advisory Committee Meeting – December 10, 2020 – FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine: “On November 20, 2020, Pfizer and BioNTech (the Sponsor) submitted an Emergency Use Authorization (EUA) request to FDA for an investigational COVID-19 vaccine (BNT162b2) intended to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine is based on the SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA and formulated in lipid nanoparticles (LNPs). The proposed use under an EUA is “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.” The proposed dosing regimen is 2 doses, 30 μg each, administered 21 days apart…”

See also Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry October 2020, U.S. Department of Health and Human ServicesFood and Drug Administration Center for Biologics Evaluation and Research.